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Auris Medical Announces Notices of Allowance for U.S. and European Patent Applications Covering Intranasal Betahistine

Received Notice of Allowance from United States Patent and Trademark Office -- Received “Intention to Grant” notice from European Patent Office

Hamilton, Bermuda, Sept. 11, 2019 (GLOBE NEWSWIRE) -- Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for its patent application entitled “Pharmaceutical Composition Comprising Betahistine” (U.S. Patent Application No. 15/887,388). In addition, the Company received an “Intention to Grant” notice from the European Patent Office (EPO) for its related patent application entitled “Intranasal Composition Comprising Betahistine” (European Patent Application 18 703 749.4). Upon issuance, the patents are expected to expire no earlier than February 2038 and will provide key intellectual property protection for the Company's intranasal betahistine program.

The allowed claims cover composition of matter and methods of use for formulations of betahistine dihydrochloride for intranasal delivery. The communications from the USPTO and EPO conclude substantive examination of the patent applications, which are now expected to issue as patents once the issue fees are paid and the patent offices conclude their respective administrative procedures. Auris Medical also has filed corresponding patent applications that will allow the Company to seek similar patent protection in other key markets throughout the world.

“We are very pleased to have achieved this major milestone in the protection of our intellectual property around the intranasal betahistine program“, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “The intranasal delivery route allows for a surprisingly strong increase in betahistine concentration in the bloodstream compared to the common oral route, which is expected to result in superior therapeutic benefits. We look forward to developing this innovation further in order to help patients who are suffering from vertigo or antipsychotic-induced weight gain, among other potential medical conditions.”

About Betahistine

Betahistine is a small molecule structural analog of histamine, which acts as an agonist at the H1 and as an antagonist at the H3 histamine receptors. Unlike histamine, it crosses the blood-brain-barrier. It is known to enhance inner ear and cerebral blood flow, increase histamine turnover and enhance histamine release in the brain, increase release of acetylcholine, dopamine and norepinephrine in the brain and to result in general brain arousal. Betahistine for oral administration is approved in about 115 countries, with the US being a notable exception, for the treatment of vertigo and Meniere’s disease. The compound has a very good safety profile, yet it is also known that its clinical utility is held back by poor bioavailability. Intranasal administration of betahistine has been shown to result in 5 to 29 times higher bioavailability.

About Auris Medical

Auris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders. The company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125) and for the treatment of antipsychotic-induced weight gain and somnolence (AM-201). These projects have gone through two Phase 1 trials and entered into proof-of-concept studies in 2019. In addition, Auris Medical has two Phase 3 programs under development: Sonsuvi® (AM-111) for acute inner ear hearing loss and Keyzilen® (AM-101) for acute inner ear tinnitus. The Company was founded in 2003 and is headquartered in Hamilton, Bermuda. The shares of Auris Medical Holding Ltd. trade on the NASDAQ Capital Market under the symbol “EARS.”

Forward-looking Statements

This press release may contain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical facts and may include statements that address future operating, financial or business performance or Auris Medical’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” or the negative of these terms and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, Auris Medical’s need for and ability to raise substantial additional funding to continue the development of its product candidates, the timing and conduct of clinical trials of Auris Medical’s product candidates and that such trials will not meet their endpoints , the clinical utility of Auris Medical’s product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical’s intellectual property position and Auris Medical’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical’s capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption “Risk Factors” in Auris Medical’s Annual Report on Form 20-F for the year ended December 31, 2018 and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

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